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Approvals of ANDAs slows

Posted by: Ken Phelps

Published on: February 21, 2011

I attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are slowing and there is a growing awareness that the root cause is not just the Office of Generic Drugs (OGD). As of January 25, 2,361 ANDAs were awaiting approval. During 2010, the median approval time slipped from 26 to over 30 months. Debra Autor, Director of FDA’s Office of Compliance illustrated why the OGD is just part of the problem. There are 192 Pre-Approval Inspections in the queue, affecting 354 ANDA submissions, but only 62 PAIs budgeted — her office lacks the manpower to conduct inspections. As the generic industry has become increasingly global, FDA is behind on transitioning its largely domestic focus. Ms. Autor said the situation is further exacerbated by the recent GAO report recommending that more resources be spent in general foreign surveillance inspections.

The generic industry continues to be perplexed at this slow pace of approvals. At the GPhA meeting, several speakers boasted about the savings of generic medicine — there were predictions that generics would represent 80% of the prescriptions within a short time. GPhA suggested that 10’s of millions of dollars would address the current problem, while saving the public billions. With the ROI so high, why can’t Congress set aside a few more million for OGD?

FDA Commissioner Dr. Margaret Hamburg seemed to agree with GPhA’s assessment. In her remarks, Dr. Hamburg said that the ANDA review issue was caused by several offices in FDA and that the only viable situation would be increased manpower. In the current Congress, additional manpower would not be budgeted, leaving her open the discussion about user fees. She spoke to the willingness of her office to hold meetings within the next few weeks.

Those readers who have followed the generic user fee issue know that there have been some discussions that haven’t gone far. Most industry members want to see something similar to PDUFA — fees for reviews and fees for products and establishments (manufacturing sites). Based on the GPhA presentations, it seems like an inspection fee could be part of the solution as well. But the size of a user fee could be a big barrier to wide industry acceptance. This clearly is an issue of the haves and have-nots; big generic companies would be able to support large fees, fees that could be out of reach for the small generic firms. PDUFA fees for an NDA that is based on a pharmacokinetic study, similar to approval requirements for an ANDA are set to $771,000 for 2011.

Another issue is what to do about the backlog — 2,300 ANDA submissions and growing every day and countless supplements and CBEs that are awaiting action. Are the user fees to be retroactive? Not likely, but where does the newly hired staff start? At last year’s GPhA it was stated that if ANDA applications ceased, it would take over 4 years to review based on the then assigned manpower.

Clearly, industry and FDA need to work together to solve this problem. GPhA leadership needs to assure that it represents all generic industry in the discussions. FDA needs to think and act globally, for example, working cooperatively with foreign compliance inspections.

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